UMIN-CTR Clinical Trial

Public title

Thoracic duct scintigraphy by orally administered I-123 BMIPP with SPECT/CT for the prevention of thoracic duct injury at the thoracic surgery for the the esophageal cancer

Acronym

Thoracic duct scintigraphy by orally administered I-123 BMIPP with SPECT/CT

Scientific Title

Thoracic duct scintigraphy by orally administered I-123 BMIPP with SPECT/CT for the prevention of thoracic duct injury at the thoracic surgery for the the esophageal cancer

Scientific Title:Acronym

Thoracic duct scintigraphy by orally administered I-123 BMIPP with SPECT/CT

Region

Japan

Condition

Esophageal cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To validate the thoracic duct imaging by orally administered I-123-labeled 15-(4-iodophenyl)-3(R,S)-methylpentadecanoic acid (BMIPP) with SPECT/CT to visualize the thoracic duct and to prevent the thoracic duct injury at the thoracic surgery.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Rate of visualization of the thoracic duct by the thoracic duct scintigraphy.
Difference among the findings of the thoracic duct scitigraphy, the other imaging modalities, and the surgical findings.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Device,equipment

Interventions/Control_1

SPECT CT scanning after the orally administration of BMIPP 111MBq.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Preoperative patients with esophageal cancer.

Key exclusion criteria

Informed consent was not obtained from the patients.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Kentaro Takanami

Organization

Tohoku university hospital

Division name

Department of Radiology

Zip code

Address

1-1 Seiryo-machi, Aoba-ku, Sendai city

TEL

022-717-7312

Email

Name of contact person

1st name
Middle name
Last name

Organization

Tohoku university hospital

Division name

Department of Radiology

Zip code

Address

1-1 Seiryo-machi, Aoba-ku, Sendai city

TEL

022-717-7312

Homepage URL

Email

Institute

Department of Radiology, Tohoku University, Graduate School of Medicine

Institute

Department

Personal name

Organization

Tohoku university hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/23027205

Number of participants that the trial has enrolled

Results

This study included 35 consecutive patients with esophageal cancer who underwent tumor resection after TD scintigraphy. For scintigraphy, 111 MBq of BMIPP was orally administered, and static images and SPECT/CT images were obtained. On the basis of the SPECT/CT fusion images, TD was divided into the following 4 segments: cervical, upper thoracic, middle thoracic, and lower thoracic. The TD visualization was categorized into 5 grades, from grade 1 (poor) to 5 (excellent). In addition, the diagnostic accuracy of 3D TD scintigraphy for the detection of anatomical anomalies of TD was calculated using the intraoperative finding as a criterion standard.
RESULTS. The TD visualization grades for the cervical, upper, middle, and lower thoracic segments were 4.4, 3.7, 3.1, and 2.1, respectively. The TD scintigraphy demonstrated an uncommon accumulation including that in the right- or bilateral-sided mediastinum or venous angle in 6 (17%) of the 35 patients. Sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of 3D TD scintigraphy for the detection of anatomical anomalies of TD were 0.75, 0.90, 0.5, 0.97, and 0.89, respectively.
CONCLUSIONS: Three-dimensional TD scintigraphy by BMIPP is a simple and minimally invasive method for imaging the anatomical configuration of the TD and for detecting any anatomical anomalies, except in the lower thoracic segment.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2009

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

06

Month

15

Day

Last modified on

2012

Year

11

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004552